National Toxicology Program

National Toxicology Program
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TDMS Study 05106-01 Pathology Tables


NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11     
LAB: Hazelton, MD                                           DIETHYLPHTHALATE                                   DATE: 05/19/95       
EXPERIMENT: 05106 TEST: 01                                                                                     TIME: 20:59:28       
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                   PAGE:       1        
CONT: NO1ES45036                                ROUTE: SKIN APPLICATION                                        NTP C#: 60048B       
PATHOLOGIST: R. CARDY                                                                                          CAS: 84-66-2         
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               REASONS FOR REMOVAL:    ALL                                                                                          
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
               REMOVAL DATE RANGE:     ALL                                                                                          
                                                                                                                                    
               TREATMENT GROUPS:       INCLUDE ALL                                                                                  

NTP                                         STATISTICAL ANALYSIS OF SURVIVAL DATA                              REPORT: PEIRPT11    
LAB: Hazelton, MD                                           DIETHYLPHTHALATE                                   DATE: 05/19/95      
EXPERIMENT: 05106 TEST: 01                                                                                     TIME: 20:59:28      
TEST TYPE:  CHRONIC                             CAGES FROM 0000 TO LAST CAGE                                                       
CONT: NO1ES45036                                ROUTE: SKIN APPLICATION                                        NTP C#: 60048B      
PATHOLOGIST: R. CARDY                                                                                          CAS: 84-66-2        

                                 DIETHYLPHTHALATE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 734 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0UL/RAT UM                               |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 46     CENSORED DEATHS 10   TERMINAL 4         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      264   399   478   502   502   520   524   527   528   548                 |
 |      549   568   568   571   578   582   583   587   591   594                 |
 |      596   597   598   600   619   626   629   629   636   636                 |
 |      644   646   651   652   668   671   673   674   680   681                 |
 |      687   691   699   702   709   730                                         |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   456   456   456                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 100UL   RAT                              |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 44     CENSORED DEATHS 10   TERMINAL 6         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      304   359   486   490   519   528   542   543   553   556                 |
 |      559   559   560   580   584   591   597   601   601   616                 |
 |      620   620   639   640   640   652   653   654   654   654                 |
 |      665   665   666   668   673   687   692   701   701   704                 |
 |      716   718   718   723                                                     |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   456   456   456                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 300UL   RAT                              |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 45     CENSORED DEATHS 9    TERMINAL 6         |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      391   413   437   486   512   519   528   533   534   534                 |
 |      535   538   542   549   559   562   563   580   582   596                 |
 |      607   612   615   626   632   637   641   645   645   647                 |
 |      650   650   654   665   667   668   689   699   699   700                 |
 |      708   708   718   722   728                                               |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   456   456                       |
 |                                                                                |
 ==================================================================================

                                 DIETHYLPHTHALATE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                     MALE RATS
                       FIRST TERMINAL SACRIFICE AT 734 DAYS


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   734 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0UL/RAT UM |   100.0 100.0  98.3  98.3  96.7  94.7  82.6  52.4  32.2   8.1      |
 |           |                                                                    |
 |           |                                                                    |
 |100UL   RAT|   100.0 100.0 100.0  96.7  96.7  96.7  84.6  62.4  36.3  12.1      |
 |           |                                                                    |
 |           |                                                                    |
 |300UL   RAT|   100.0 100.0 100.0 100.0  96.7  95.0  75.2  61.4  33.6  11.9      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                    DOSE                        |
 |                                                                                |
 |                                0UL/RAT UM       100UL   RAT      300UL   RAT   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|        8.1%            12.1%            11.9%         |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.640N         P=0.313N         P=0.545N      |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       599.7            610.3            602.8         |
 |NATURAL DEATHS (C)      |       (12.7)           (13.4)           (12.5)        |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       584.7            596.9            593.9         |
 |(STANDARD ERROR)        |       (13.0)           (13.7)           (13.0)        |
 |                        |                                                       |
 ==================================================================================
                                    


       (A)  FIRST TERMINAL SACRIFICE
       (B)  THE FIRST ENTRY IS THE TREND TEST (TARONE, 1975) RESULT.
            SUBSEQUENT ENTRIES ARE THE RESULTS OF PAIRWISE TESTS
            (COX,1972).  NEGATIVE TRENDS ARE INDICATED BY "N".
       (C)  MEAN OF ALL UNCENSORED DEATHS PRIOR TO TERMINAL SACRIFICE
       (D)  MEAN OF ALL DEATHS (UNCENSORED, CENSORED, TERMINAL SACRIFICE)

                                 DIETHYLPHTHALATE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 734 DAYS
                                                          


                          INDIVIDUAL SURVIVAL TIMES (DAYS)
 ==================================================================================
 |                                DOSE = 0UL/RAT UF                               |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 21     CENSORED DEATHS 9    TERMINAL 30        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      331   458   465   551   552   555   562   569   569   593                 |
 |      612   650   655   656   679   683   705   717   724   730                 |
 |      731                                                                       |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   456   456                       |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 100UL   RAT                              |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 22     CENSORED DEATHS 10   TERMINAL 28        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      419   434   494   545   551   555   567   568   573   574                 |
 |      600   640   645   650   654   655   659   673   675   687                 |
 |      713   733                                                                 |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   456   456   456                 |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                DOSE = 300UL   RAT                              |
 |                             ---------------------                              |
 |                                                                                |
 |  TOTAL 60     UNCENSORED DEATHS 27     CENSORED DEATHS 10   TERMINAL 23        |
 |                                                                                |
 |  UNCENSORED DEATHS                                                             |
 |      344   367   430   489   520   541   543   549   559   569                 |
 |      584   585   588   591   595   611   626   638   639   657                 |
 |      658   675   680   687   689   706   729                                   |
 |  CENSORED DEATHS                                                               |
 |      456   456   456   456   456   456   456   456   456   456                 |
 |                                                                                |
 ==================================================================================

                                 DIETHYLPHTHALATE


                       STATISTICAL ANALYSIS OF SURVIVAL DATA
                                    FEMALE RATS
                       FIRST TERMINAL SACRIFICE AT 734 DAYS


 ==================================================================================
 |               KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%)                  |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |    DOSE                               TIME (DAYS)                              |
 |                 90   180   270   365   425   485   545   605   665   734 (A)   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |           |                                                                    |
 |0UL/RAT UF |   100.0 100.0 100.0  98.3  98.3  94.4  94.4  80.6  72.8  59.0      |
 |           |                                                                    |
 |           |                                                                    |
 |100UL   RAT|   100.0 100.0 100.0 100.0  98.3  96.7  92.6  78.5  66.5  56.4      |
 |           |                                                                    |
 |           |                                                                    |
 |300UL   RAT|   100.0 100.0 100.0  98.3  96.7  95.0  86.9  70.7  58.6  46.5      |
 |           |                                                                    |
 |           |                                                                    |
 ==================================================================================
 ==================================================================================
 |                           SURVIVAL SUMMARY STATISTICS                          |
 |                                                                                |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |                                                    DOSE                        |
 |                                                                                |
 |                                0UL/RAT UF       100UL   RAT      300UL   RAT   |
 |                                                                                |
 |--------------------------------------------------------------------------------|
 |SURVIVAL AT END OF STUDY|       59.0%            56.4%            46.5%         |
 |(KAPLAN-MEIER)          |                                                       |
 |                        |                                                       |
 |SIGNIFICANCE (B)        |       P=0.162          P=0.835          P=0.202       |
 |(LIFE TABLE)            |                                                       |
 |                        |                                                       |
 |MEAN DAY OF             |       607.0            602.9            587.0         |
 |NATURAL DEATHS (C)      |       (22.7)           (17.8)           (18.5)        |
 |(STANDARD ERROR)        |                                                       |
 |                        |                                                       |
 |MEAN LIFE SPAN (D)      |       647.9            639.6            621.5         |
 |(STANDARD ERROR)        |       (15.1)           (14.7)           (15.4)        |
 |                        |                                                       |
 ==================================================================================
                                    


       (A)  FIRST TERMINAL SACRIFICE
       (B)  THE FIRST ENTRY IS THE TREND TEST (TARONE, 1975) RESULT.
            SUBSEQUENT ENTRIES ARE THE RESULTS OF PAIRWISE TESTS
            (COX,1972).  NEGATIVE TRENDS ARE INDICATED BY "N".
       (C)  MEAN OF ALL UNCENSORED DEATHS PRIOR TO TERMINAL SACRIFICE
       (D)  MEAN OF ALL DEATHS (UNCENSORED, CENSORED, TERMINAL SACRIFICE)

                                                          DIETHYLPHTHALATE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0UL/RAT UM       = 1
                                                        100UL   RAT      = 2
                                                        300UL   RAT      = 3

------------------------------------------------------ SPECIES=RATS SEX=MALE -------------------------------------------------------

                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.

      |
      |
  100 + 1                                         1     2             3
      |                                           1     2        2    31 3   3      12
      |                                                                      3      13 1
      |                                                                              2   3 2
   90 +                                                                                1 3 12
      |                                                                                    1132
      |                                                                                       22
      |                                                                                     1  12
   80 +
      |                                                                                      331  1
      |                                                                                       332  2
      |                                                                                        333112
P  70 +                                                                                            11 2
E     |                                                                                          3 3  22
R     |                                                                                            31 1
C     |                                                                                             3  232
E  60 +                                                                                               11322
N     |                                                                                                   2  2
T     |                                                                                                  3 3
      |                                                                                                1  133
S  50 +                                                                                                   1132 2
U     |                                                                                                      33
R     |                                                                                                    11
V     |
I  40 +                                                                                                     11 2 2
V     |                                                                                                      113 22
A     |                                                                                                       11 3
L     |                                                                                                        1 312
   30 +                                                                                                           32 2
      |                                                                                                           11 33
      |                                                                                                            112 2
      |                                                                                                               3 3
   20 +                                                                                                             11 2 2
      |                                                                                                                 33
      |                                                                                                              111 22
      |                                                                                                                11 2 2
   10 +                                                                                                                 1   1
      |                                                                                                                     1
      |
      |
    0 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 31 obs hidden.

                                                          DIETHYLPHTHALATE
                                                    KAPLAN-MEIER SURVIVAL CURVES
                                                        0UL/RAT UF       = 1
                                                        100UL   RAT      = 2
                                                        300UL   RAT      = 3

----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------

                                         Plot of SURVIVAL*WEEK.  Symbol is value of DOSE.

      |
      |
  100 + 1                                                    1 3          2
      |                                                      1 3  3       2 2    11   2
      |                                                                     3     1  32       21
      |                                                                              3     3  22
P  90 +                                                                                    3  311
E     |                                                                                       33111
R     |                                                                                        33
C     |                                                                                         3 1   1
E  80 +                                                                                           2 3 12 1
N     |                                                                                                2 1   211
T     |                                                                                             3 3
      |                                                                                                       21   1
S  70 +                                                                                               3  3         11  1
U     |                                                                                                  3 3 3 2 2 2   1 1
R     |                                                                                                                  11
V     |                                                                                                      3 3   2 2    1 1
I  60 +                                                                                                              2  2   1
V     |                                                                                                        3   33   2   2
A     |                                                                                                             33
L     |
   50 +                                                                                                              3 3
      |                                                                                                                3    3
      |
      |
   40 +
      |
      --+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+----------+--
        0         10         20         30         40         50         60         70         80         90         100        110

                                                                   WEEK

NOTE: 25 obs hidden.
NTP is located at the National Institute of Environmental Health Sciences, part of the National Institutes of Health.